UNI EN 550 : 1996
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION
01-06-2010
01-01-1996
Cooperating organizations
National foreword
Foreword
Introduction
1. Scope
2. Normative references
3. Definitions
4. General
5. Validation
6. Process control and monitoring
7. Product release from sterilization
Annexes
A. (normative) Method for calculating D-values using
microbiological performance qualification method B
B. (informative) Guidance on the application of EN 550
C. (informative) Bibliography
National annex NA (informative) Committees responsible
National annex NB (informative) Cross-references
Specifies requirements for the development, validation, process control and monitoring of the sterilisation of medical devices using ethylene oxide. Coverage includes definitions, validation, product release from sterilisation, and process control and monitoring. Also gives detailed annexes.
| DocumentType |
Standard
|
| PublisherName |
Ente Nazionale Italiano di Unificazione (UNI)
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| UNE-EN 550:1995 | Identical |
| I.S. EN 550:1994 | Identical |
| EN 550 : 1994 | Identical |
| BS EN 550:1994 | Identical |
| DIN EN 550:1994-11 | Identical |
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